Ziomycin Adverse Reactions

Ziomycin is well tolerated with a low incidence of side effects.
The section as follows lists the adverse reactions identified through clinical trial experience and postmarketing surveillance by system organ class and frequency. Adverse reactions identified from postmarketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Adverse reactions possibly or probably related to azithromycin based on clinical trial experience and post marketing surveillance: Infections and Infestations: Uncommon: Candidiasis, oral candidiasis, vaginal infection.
Not known: Pseudomembranous colitis (see Precautions).
Blood and Lymphatic System Disorders: Uncommon: Leukopenia, neutropenia.
Not known: Thrombocytopenia, haemolytic anaemia.
Immune System Disorders: Uncommon: Angioedema, hypersensitivity.
Not known: Anaphylactic reaction (see Precautions).
Metabolism and Nutrition Disorders: Common: Anorexia.
Psychiatric Disorders: Uncommon: Nervousness.
Rare: Agitation.
Not known: Aggression, anxiety.
Nervous System Disorders: Common: Dizziness, headache, paraesthesia, dysgeusia.
Uncommon: Hypoaesthesia, somnolence, insomnia.
Not known: Syncope, convulsion, psychomotor hyperactivity, anosmia, ageusia, parosmia, Myasthenia gravis (see Precautions).
Eye Disorders: Common: Visual impairment.
Ear and Labyrinth Disorders: Common: Deafness.
Uncommon: Hearing impaired, tinnitus.
Rare: Vertigo.
Cardiac Disorders: Uncommon: Palpitations.
Not known: Torsades de pointes (see Precautions), arrhythmia (see Precautions) including ventricular tachycardia.
Vascular Disorders: Not known: Hypotension.
Gastrointestinal Disorders: Very common: Diarrhoea, abdominal pain, nausea, flatulence.
Common: Vomiting, dyspepsia.
Uncommon: Gastritis, constipation.
Not known: Pancreatitis, tongue discolouration.
Hepatobiliary Disorders: Uncommon: Hepatitis.
Rare: Hepatic function abnormal.
Not known: Hepatic failure (see Precautions), which has rarely resulted in death, hepatitis fulminant, hepatic necrosis, jaundice cholestatic.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus and rash.
Uncommon: SJS, photosensitivity reaction, urticarial.
Rare: Acute Generalized Exanthematous Pustulosis (AGEP)*^§.
Very Rare: DRESS.
Not known: TEN, erythema multiforme.
Musculoskeletal, Connective Tissue Disorders: Common: Arthralgia.
Renal and Urinary Disorders: Not known: Renal failure acute, nephritis interstitial.
General disorders and Administration Site Conditions: Common: Fatigue.
Uncommon: Chest pain, oedema, malaise, asthenia.
Investigations: Common: Lymphocyte count decreased, eosinophil count increased, blood bicarbonate decreased.
Uncommon: Aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, blood urea increased, blood creatinine increased, blood potassium abnormal.
Not known: Electrocardiogram QT prolonged (see Precautions).
*ADR identified post-marketing.
^§ADR frequency represented by the estimated upper limit of the 95% confidence interval calculated using the "Rule of 3".
Adverse Drug Reaction: "Inform doctors about unexpected reactions after using drugs."